Skip to Content

TELMISARTAN EGIS 80MG FILM-COATED TABLETS

Active substance(s): TELMISARTAN / TELMISARTAN / TELMISARTAN

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user
Telmisartan EGIS 20mg film-coated tablets
Telmisartan EGIS 40mg film-coated tablets
Telmisartan EGIS 80mg film-coated tablets
telmisartan
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1.
What Telmisartan EGIS is and what it is used for
2.
What you need to know before you take Telmisartan EGIS
3.
How to take Telmisartan EGIS
4.
Possible side effects
5.
How to store Telmisartan EGIS
6.
Contents of the pack and other information
1.

What Telmisartan Egis is and what it is used for

Telmisartan EGIS belongs to a class of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus
increasing your blood pressure. Telmisartan EGIS blocks the effect of angiotensin II so that the blood
vessels relax, and your blood pressure is lowered.
Telmisartan EGIS is used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means
that the high blood pressure is not caused by any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes
to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood
pressure before damage occurs. Thus it is important to regularly measure blood pressure to verify if it is
within the normal range.
Telmisartan EGIS is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adult patients
who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a
stroke or have high risk diabetes. Your doctor can tell you if you are at high risk for such events.
2.

What you need to know before you take Telmisartan EGIS

Do not take Telmisartan EGIS
• If you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• If you are more than 3 months pregnant. (It is also better to avoid Telmisartan EGIS in early pregnancy
– see pregnancy section.)
• If you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage
of the bile from the liver and gall bladder) or any other severe liver disease.



If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering
medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan EGIS.
Warnings and precautions
Talk to your doctor or pharmacist before taking Telmisartan EGIS.
Talk to your doctor if you are suffering or have ever suffered from any of the following conditions or
illnesses:









Kidney disease or kidney transplant.
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Liver disease.
Heart trouble.
Raised aldosterone levels (water and salt retention in the body along with imbalance of various blood
minerals).
Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water)
or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea, or vomiting.
Elevated potassium levels in your blood.
Diabetes.

Talk to your doctor before taking Telmisartan EGIS:
• if you are taking any of the following medicines used to treat high blood pressure:
- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetesrelated kidney problems.
- aliskiren.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals. See also information under the heading “Do not take
Telmisartan EGIS”.
• if you are taking digoxin.
You must tell your doctor if you think you are (or might become) pregnant. Telmisartan EGIS is not
recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may
cause serious harm to your baby if used at that stage (see pregnancy section).
In case of surgery or anaesthesia, you should tell your doctor that you are taking Telmisartan EGIS.
Telmisartan EGIS may be less effective in lowering the blood pressure in black patients.
Children and adolescents
The use of Telmisartan EGIS in children and adolescents up to the age of 18 years is not recommended.
Other medicines and Telmisartan EGIS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor may need to change your dose and/or take other precautions. In some cases you may have to
stop taking one of the medicines. This applies especially to the medicines listed below taken at the same
time with Telmisartan EGIS:





Lithium containing medicines to treat some types of depression.
Medicines that may increase blood potassium levels such as salt substitutes containing potassium,
potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor
antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or
ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic
trimethoprim.
Diuretics ('water tablets'), especially if taken in high doses together with Telmisartan EGIS may lead to




excessive loss of body water and low blood pressure (hypotension).
If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not
take Telmisartan EGIS” and “Warnings and precautions”).
Digoxin.

The effect of Telmisartan EGIS may be reduced when you take NSAIDs (non steroidal anti-inflammatory
medicines, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartan EGIS may increase the blood pressure lowering effect of other medicines used to treat high
blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen, amifostine).
Furthermore, low blood pressure may be aggravated by alcohol, barbiturates, narcotics or
antidepressants. You may notice this as dizziness when standing up. You should consult with your doctor
if you need to adjust the dose of your other medicine while taking Telmisartan EGIS.
Telmisartan EGIS with food and drink
You can take Telmisartan EGIS with or without food.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally
advise you to stop taking Telmisartan EGIS before you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine instead of Telmisartan EGIS.
Telmisartan EGIS is not recommended in early pregnancy, and must not be taken when more than 3
months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan EGIS is not
recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you
if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Some people feel dizzy or tired when taking Telmisartan EGIS. If you feel dizzy or tired, do not drive or
operate machinery.
Telmisartan EGIS contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.
3.

How to take Telmisartan EGIS

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
The recommended dose of Telmisartan EGIS is one tablet a day. Try to take the tablet at the same time
each day.
You can take Telmisartan EGIS with or without food. The tablets should be swallowed with some water or
other non-alcoholic drink.
It is important that you take Telmisartan EGIS every day until your doctor tells you otherwise.
If you have the impression that the effect of Telmisartan EGIS is too strong or too weak, talk to your
doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan EGIS for most patients is one
40 mg tablet once a day to control blood pressure over the 24-hour period. However, sometimes your
doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg.
Telmisartan EGIS may also be used in combination with diuretics ('water tablets') such as
hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with
Telmisartan EGIS.
For reduction of cardiovascular events, the usual dose of Telmisartan EGIS is one 80 mg tablet once a day.
At the beginning of the preventive therapy with Telmisartan EGIS 80 mg, blood pressure should be
frequently monitored.
If your liver is not working properly, the usual dose should not exceed 40 mg once daily.
If you take more Telmisartan EGIS than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest hospital
emergency department immediately.
If you forget to take Telmisartan EGIS
If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as before. If you
do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Telmisartan EGIS
Do not stop taking Telmisartan EGIS without talking to your doctor.
Medicines for high blood pressure may need to be taken for the rest of your life. If you stop taking
Telmisartan EGIS your blood pressure will return to the level it was before treatment in a few days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
You should see your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response),
rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1,000
people) but are extremely serious and patients should stop taking the medicine and see their doctor
immediately. If these effects are not treated they could be fatal.
Possible side effects of Telmisartan EGIS:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon side effects (may affect up to 1 to 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold),
deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad
(depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood
pressure (hypotension) in users treated for high blood pressure, dizziness or standing up (orthostatic
hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating,
vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney
impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of
creatinine in the blood.

Rare side effects (may affect up to 1 in 1,000 people):
Sepsis* (often called “blood poisoning”, is a severe infection with whole-body inflammatory response which
can lead to death), increase in certain white blood cells (eosinophilia), low platelet count
(thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash,
itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood
sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat
(tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese
patients are more likely to experience these side effect), rapid swelling of the skin and mucosa which can
also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives
(urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased
haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine
phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease)**.
* The event may have happened by chance or could be related to a mechanism currently not known.
** Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
However, it is not known whether telmisartan was the cause.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5.

How to store Telmisartan EGIS

Store in the original package in order to protect from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help protect the environment
6.

Contents of the pack and other information

What Telmisartan EGIS contains
The active substance is telmisartan, each tablet contains 20mg/40mg/80mg telmisartan.
The other ingredients are:
Sodium Hydroxide
Povidone (K-25)
Meglumine
Lactose Monohydrate
Crospovidone
Ferric oxide yellow (E172)
Magnesium Stearate
The film-coating contains:
Hypromellose

Titanium Dioxide (E171)
Macrogol-400
Talc
Ferric oxide yellow (E172)
What Telmisartan EGIS looks like and contents of the pack
Telmisartan EGIS 20 mg are yellow, circular shaped film coated tablets with ‘20’ engraved on one side and
‘T’ engraved on the other side.
Telmisartan EGIS 40 mg are yellow, capsule shaped film coated tablets with ‘40’ engraved on one side and
‘T’ engraved on the other side.
Telmisartan EGIS 80 mg are yellow, capsule shaped film coated tablets with ‘80’ engraved on one side and
‘T’ engraved on the other side.
Telmisartan EGIS is available in blister packs containing 14, 15, 28, 30, 56, 60, 84, 90 or 98 tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EGIS Pharmaceuticals PLC
H-1106 Budapest, Keresztúri út 30-38.
Hungary
Manufacturer
Tillomed Laboratories Limited.
Glenmark Pharmaceuticals sro.
City Tower, Hvezdova 1716/2B,
Prague 4, CZ-140 78,
Czech Republic
Glenmark Pharmacuticals EuropeLimited.
Building 2, Croxley Green Business Park
Croxley Green,
Hertfordshire, WD18 8YA,
United Kingdom
EGIS Pharmaceuticals PLC
H-1165, Budapest, Bökényföldi út 118-120,
Hungary.
This medicinal product is authorised in the Member States of the EEA under the following names:
Telmisartan Egis 20mg/40mg/80mg film-coated tablets
United Kingdom:
Bulgaria:
Telmisartan Egis 20mg/40mg/80mg филмирани таблетки
Czech Republic:
Telmisartan Egis 20mg/40mg/80mg
Hungary:
Telmisartan Egis 20mg/40mg/80mg filmtabletta
Lithuania:
Telmisartan Egis 20mg/40mg/80mg plėvele dengtos tabletės
Latvia:
Telmisartan Egis 20mg/40mg/80mg apvalkotās tabletes
Poland:
Telmisartan Egis
Romania:
Telmisartan Egis 20mg/40mg/80mg comprimate filmate

Slovakia:

Telmisartan Egis 20mg/40mg/80mg

This leaflet was last revised in 06/2016.
POM
PL 03525/0023-001
PL 03525/0024-001
PL 03525/0025-001

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide